Adult Oxygen Mask High Concentration

GUDID 50628725096921

High Concentration, 7ft. Saflo Tube - multi-fit on one end

Canadian Hospital Specialties Limited

Rebreathing oxygen face mask
Primary Device ID50628725096921
NIH Device Record Key6f512a4e-bc16-4bd8-9c31-0e4459d25b95
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdult Oxygen Mask High Concentration
Version Model NumberR-2450SM
Company DUNS240992693
Company NameCanadian Hospital Specialties Limited
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100628725096926 [Primary]
GS150628725096921 [Package]
Contains: 00628725096926
Package: Corrugate Case [50 Units]
In Commercial Distribution

FDA Product Code

KGBMask, Oxygen, Non-Rebreathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-04
Device Publish Date2024-02-23

Devices Manufactured by Canadian Hospital Specialties Limited

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50628725095139 - MISI-Medical Imaging Solutions International2025-08-15 CT ANGIOGRAPHIC SYRINGE 1-200ml syringe. 1-Large Spike. 1-Fill Straw. 1-60" Coiled Tubing. 1-Drip Tube with Plug
00628725095226 - MISI-Medical Imaging Solutions International2025-08-15 CT Angiographic Syringe 2-200ml Syringes, 2-Fill Straws, 1-Large Spike, 1-Small Spike, 1-Drip tubing with plug, -1-60" T Coiled
50628725095238 - MISI-Medical Imaging Solutions International2025-08-15 CT Angiographic Syringe 2-200ml Syringes, 2-Fill Straws, 2-Large Spikes, 1-Drip tubing with plug, 1-60" T Coiled tubing with Dua
50628725095245 - MISI-Medical Imaging Solutions International2025-08-15 CT Angiographic Syringe 1-200ml Syringe, 1-60" Coiled Tubing, 1-Fill Straw, 1-Large Spike, 1-Drip tubing with plug
50628725095146 - MISI-Medical Imaging Solutions International2025-07-15 CT ANGIOGRAPHIC SYRINGE 2-200ml syringes, 1-60" Y coiled tubing with dual check valves, 2 - Large Spikes, 1 - Fill Staw, 1- Dr

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